Package Insert: Information for the User

Terbinafine Alter 250 mg Tablets

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4

Terbinafina belongs to a group of medications known as antifungals and acts by preventing the development of fungi.

Terbinafina Alter is used for the treatment of the following fungal skin, scalp, and nail infections:

Tinea corporis(body ringworm).

Tinea cruris(inguinal ringworm or jock itch).

Tinea pedis(athlete's foot).

Tinea capitis(scalp ringworm).

Onychomycosis (nail ringworm).

Do not take Terbinafina Alter

• if you are allergic to terbinafine or any of the other ingredients of this medication (listed in section 6).
• if you have severe kidney or liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Terbinafina Alter

• if you have kidney or liver problems, consult your doctor before taking this medication.
• if you have psoriasis (a skin disease), as in very rare cases, the disease may worsen.

It is essential to inform your doctor immediately if you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite, unusual fatigue or weakness, if your skin or the white part of your eyes turns yellow, if you notice a darkening of your urine or pale stools.

Inform your doctor immediately if you experience sore throat accompanied by fever and chills, unusual bleeding or bruising, or any severe skin problems.

Children

The experience with terbinafine in children is limited, therefore, it is not recommended for use in these patients.

Older patients

Terbinafina Alter can be administered to patients over 65 years of age.

Patients with kidney problems

If you have pre-existing renal problems, you may be prescribed a lower than usual dose.

Patients with liver problems

Terbinafina Alter is not recommended for patients who have or have had liver problems in the past.

Other medications and Terbinafina Alter

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

There are other medications that may modify the effect of Terbinafina Alter, for example:

• some antibiotics (e.g. rifampicin),
• some antidepressants (e.g. desipramine),
• some medications used to treat heart problems (e.g. propafenone),
• some medications used to treat high blood pressure (e.g. metoprolol),
• some medications used to treat stomach ulcers (e.g. cimetidina),
• some medications used to prevent organ rejection in transplant patients (e.g. ciclosporina).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Terbinafina Alter should not be administered during pregnancyTherefore, before taking this medication, inform your doctor if you are pregnant or become pregnant during treatment.

Breastfeeding

Terbinafine passes into breast milk, therefore, its use is not recommended during the breastfeeding period.

Driving and operating machinery

Terbinafina Alter has no effect on the ability to drive and operate machinery.

Terbinafina Alter contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage:

The recommended dose in adults is one tablet (250 mg) once a day.

Treatment duration:

The treatment duration will be established by your doctor. Do not discontinue treatment beforehand, as this may worsen your condition.

It is possible that the complete resolution of symptoms from the infection may not occur until several weeks (skin and scalp) or months (nails) after the disappearance of the fungus causing the infection.

Administration form:

Terbinafina Alter are oral tablets. Swallow the tablets whole, without chewing, with a glass of water.

If you take more Terbinafina Alter than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested..

The main symptoms of acute intoxication may be gastrointestinal, e.g., nausea, abdominal pain, or vomiting, but dizziness or headache may also occur. If you experience any of these effects or any other unusual effect, consult your doctor.

If you forgot to take Terbinafina Alter

Take another one as soon as you remember, unless it is less than 6 hours before the next dose.

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects are generally mild or moderate, and temporary.

Some rare or very rare side effects that can be severe:

Rarely, Terbinafina Alter can cause liver problems and in very rare cases, these problems can be severe. Very rare adverse reactions include a decrease in certain blood cells, lupus (an autoimmune disease) or severe skin reactions, including allergic reactions.

Inform your doctor immediately:

• If you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite or unusual fatigue or weakness.
• If you notice that your skin or the white of your eyes turns yellow, that your urine is unusually dark or that you have pale stools.
• If you experience sore throat accompanied by fever and chills
• If you experience unusual bleeding or bruising.
• If you develop any skin problem.

Other side effects:

Very common (can affect more than 1 in 10 people):nausea, mild abdominal pain, gastric discomfort, diarrhea, feeling of fullness in the stomach, loss of appetite, skin rash, joint or muscle pain.

Common (can affect up to 1 in 10 people):headache.

Uncommon (can affect up to 1 in 100 people):alteration of taste or loss of taste that usually recovers within a few weeks of treatment interruption. This can lead, in very few patients, to a decrease in appetite and significant weight loss. Inform your doctor if the alteration of taste lasts for several days.

Rare (can affect up to 1 in 10,000 people):hair loss, intense weakness, skin eruptions of the type psoriasis, worsening of psoriasis.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicinesshould not be thrown down the drains or in the trash.Dispose of the packaging and themedicinesyou no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Terbinafina Alter

• The active ingredient is terbinafine. Each tablet contains 250 mg of terbinafine (as hydrochloride).
• The other components (excipients) are: magnesium stearate, hypromellose, anhydrous colloidal silica, carboxymethylcellulose sodium (from potato), microcrystalline cellulose.

Appearance of the product and content of its packaging

Terbinafina Alter 250 mg is presented in the form of tablets. The tablets are breakable, with a notch on both faces, oblong and white in color. It is presented in packaging of 14 or 28 tablets.

Holder of the marketing authorization

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing

Liconsa, S.A.

Avda. Miralcampo, 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Madrid

Spain

Last review date of this leaflet:April 2006